FDA Update 2011 presented
by Bennett Napier, CAE
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FDA Enforcement Statistics Summary 2010
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Type of Enforcement
Seizures
Injunctions
Convictions
Warning Letters
Recalls
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Number of Instances
8
5
369
445
2,721
FDA Enforcement Statistics Summary 2010
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Type of Enforcement
483 Letters Issued
Inspections
Import Refusals
Fines
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Number of Instances
4,987
15,245
17,907
$846,591,080
Top Ten Warning Letter Cites for Medical Devices
including dental- 2010
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21
21
21
21
21
CFR
CFR
CFR
CFR
CFR
820.22
41
820.30(g) 28
820.198(a) 28
820.75(a) 27
820.100(a) 25
Quality Audit
Design Controls
Complaint File
Process Validation
CAPA
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Top Ten Warning Letter Cites for Medical Devices
including dental- 2010
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21
21
21
21
21
CFR
CFR
CFR
CFR
CFR
820.30(i) 21 Design Controls
820.184 21 Device Record
820.30(a) 20 Design Controls
820.80(d) 19 Receiving
820.198(c) 19 Complaint File
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Sixteen Device Specialty Categories
21 CFR (part 800-1299)
Medical Device Definition in Sec 201(h) of the FD&C Act
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872 Dental
874 Ear, nose and throat
876 Gastroenterology & urology
devices
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878 General and plastic surgery
880 General hospital and
personal use
882 Neurological
Medical Device Reporting
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Another key regulatory development is an announcement by the FDA in August 2009 that
beginning February 2011 medical device manufacturers, importers and facilities will be required
to submit Adverse Event Reports (AERs) to CDRH electronically.
Currently, CDRH receives most incident reports on paper which then needs to be input into the
Manufacturer and User Facility Device Experience (MAUDE) database.
The FDA says the existing process is not only costly, but hinders CDRH’s ability to review safety
data quickly to uncover potential public health problems. USFDA has posted information about
this new initiative to its website.
Medical Device Reporting (MDR)
“Adverse Event Reporting”
(21 CFR Part 803)
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Mechanism for FDA to identify and monitor significant adverse events
involving medical devices. New requirements is that reporting is all
done online now at fda.gov no more paper submissions
Events:
Death, Serious Injury and Malfunction
Reported by:
Manufacturer, User Facility, and Importers of medical devices
References of Note for 2011
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2011 FDA Budget Request (dental laboratories mentioned by name)
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM20
2323.pdf
Unique Device Identifier Program Excerpt - “UDI impact on dental laboratories and other custom
devices are not yet clear to some in industry. Labs making custom products under DDS direction
are not registered as manufacturers. Some DDS still have their own lab in the practice.”
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIden
tifiers/UCM235964.pdf UDI reference to dental laboratories
Import Posture for FDA
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Fiscal Year 2010 – 20 million shipments of FDA regulated imports
U.S. Government Accountability Office report to Congress in 2010
indicated only 8% of shipments are being inspected
Budget request for additional $70 million in funding to increase at port
inspections of imported products
Dental Laboratory Data for Import Restorations 2010
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(NAICS) codes comprise the medical devices industry that is covered by the Office of
Health and Consumer Goods (OHCG) Based on FDA 2010 data, total medical device
imports for the U.S. was $33 billion
According to the FDA data, Dental laboratories (NAIC 339116; account for about 4
percent of import total measured by value of shipment (VOS) include crowns, dentures,
bridges and other orthodontic products.
4 percent equals $1.32 billion. If you use IDATA Research as measure which speculates
$10.7 billion in sales, % is 12%. If you use NADL/ADA data on U.S. lab sales, percentage is
20%. Again this is percentage of sales not units. If you use units as the measure based on
average offshore price point, its likely to be 35% of units.
FDA Automated System
OASIS System (Operational and
Administrative System for Import Support)
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OASIS is an automated FDA system for processing and
making admissibility determinations for shipments of
foreign-origin, FDA-regulated products seeking to enter
U.S. commerce.
PREDICT System
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FDA's new PREDICT risk-based screening system for imports is coming
soon.
It will replace the admissibility screening function of OASIS, FDA's
legacy system.
PREDICT will assist entry reviewers in targeting higher-risk shipments
for examination.
It will also expedite the clearance of lower-risk cargo, but only if
accurate and complete data are provided by importers and entry filers.
Labeling Reminder
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Sec. 801.1 Medical devices; name and place of business of manufacturer, packer or
distributor.
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(a) The label of a device in package form shall specify conspicuously the name and place of
business of the manufacturer, packer, or distributor.
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(b) The requirement for declaration of the name of the manufacturer, packer, or distributor
shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate
name which may be preceded or followed by the name of the particular division of the
corporation. Abbreviations for "Company," "Incorporated," etc., may be used and "The" may be
omitted. In the case of an individual, partnership, or association, the name under which the
business is conducted shall be used.
Labeling Reminder
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Sec. 801.1 Medical devices; name and place of business of manufacturer,
packer or distributor.
(c) Where a device is not manufactured by the person whose name
appears on the label, the name shall be qualified by a phrase that reveals
the connection such person has with such device; such as,
"Manufactured for ___", "Distributed by _____", or any other wording
that expresses the facts
Labeling Reminder - continued
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.(d) The statement of the place of business shall include the street address, city, State, and Zip
Code; however, the street address may be omitted if it is shown in a current city directory
or telephone directory. The requirement for inclusion of the ZIP Code shall apply only to consumer
commodity labels developed or revised after the effective date of this section. In the case of
nonconsumer packages, the ZIP Code shall appear on either the label or the labeling (including the
invoice).
(e) If a person manufactures, packs, or distributes a device at a place other than his
principal place of business, the label may state the principal place of business in lieu of the
actual place where such device was manufactured or packed or is to be distributed, unless
such statement would be misleading.
Office of Regulatory
Affairs (ORA)
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ORA is the lead office for all
FDA field activities as well as
providing FDA leadership on
imports, inspections, and
enforcement policy.
Inspection Preparation
Preparing Ahead For an
FDA Inspection
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General Tips
• The time to start preparing for an FDA inspection is before
they call.
• Keep all records and documents current and appropriately
filed (easily accessible)
• Keep all communications from different studies separate
from each other
Preparing Ahead For an FDA Inspection
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Document and file all pertinent communication with
key sponsor personnel and with other external
personnel (vendors, project partners, etc.)
Conduct periodic QC reviews to ensure data
integrity
Identify/know team/personnel who will
interact/respond to FDA during an inspection
Preparing Ahead For an FDA Inspection
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Ensure all staff are educated on proper conduct
during an FDA inspection
Know GCPs, regulations/guidelines, SOPs and
study specific information (or at least know how to
access resources to get the information)
FDA Inspection Outcomes
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No inspectional findings
FDA 483 Observations
• Documents non-compliance with regulations only (can not cite for noncompliance with guidelines)
• May be left at the site at the end of the inspection or sent later
• EIR (Establishment Inspection Report)
• Will list findings: non-compliance with both regulations and guidelines
• Site/Organization may or may not receive a copy
Compliance Classifications
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NAI –
No Action Indicated
Inspected firm is in compliance
VAI Voluntary Action Indicated
Deviation(s) from the regulations
Voluntary correction is requested
OAI Official Action Indicated
Because of serious non-compliance requiring regulatory or administrative
action by FDA
Adequate FDA 483 Response
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Submit a prompt written response
-assess the root cause of the problem
-Explain actions to correct the problem
-Evaluate the extent of the problem
-Implement preventative actions to avoid recurrence
-include supporting documentation
-provide REALISTIC timelines for implementation and correction
Q&A with FDA
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Question: If a foreign dental laboratory is "partially finishing" dental
restorations and shipping them to domestic dental laboratories as a
component and not a finished case does that trigger the domestic lab to
register as an Initial Importer?
Answer: The domestic lab would not necessarily have to register as an
initial importer of a component, however, they should be registering as
repackager / relabeler if they are taking a finished device that they
imported and changing the original labeling and packaging from that being
provided by the foreign dental laboratory. The imported case must comply
with the applicable 801 labeling regulations.
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Q
&
A
with
FDA
Question: What are special requirements for dental laboratories that make sleep
apnea/snoring devices“? Dentists prescribe the device and the dental laboratory makes the
device.
Answer: Due to the classification of such devices, a dental laboratory may have to register
as a contract manufacturer. If a dental laboratory manufactures a sleep apnea/snoring
device then they have to follow the guidance given by ODE regarding when they are a
manufacturer. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Guidanc
eDocuments/ucm072728.htm
If a dental laboratory advertises to dentists that they can make a snoring appliance of their
own design, then the dental laboratory is operating as a manufacturer of a finished device
and no longer solely operating as a dental laboratory.
Q & A with FDA
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Question: As it relates to point of origin labeling, our understanding from previous FDA
responses is, that a dental laboratory that outsources domestically or to a foreign dental
laboratory has to disclose such in labeling to the dentist, by providing company name,
physical address of the third party provider, whether, the restoration was outsourced in full
or part? Is that the correct interpretation?
Answer: When a dental device is manufactured by a foreign dental laboratory it must be
labeled in compliance with the requirements of 21 CFR 801.1 Medical devices; name and
place of business of manufacturer, packer or distributor. If the importer (domestic dental
laboratory) decides to repackage and relabel the dental device, then the labeling must also
comply with 801.1. There are no FDA regulations requiring the disclosure of what
percentage of a device was outsourced for manufacturing, or the country of origin of a
device. Country of origin requirements come from U.S. Customs and Border Protection.
Q &A With FDA
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Question: If an individual dental laboratory in one physical
location is manufacturing sleep apnea devices does each
location need to register if it is a branch location of a
conglomerate?
Answer: Each individual dental laboratory that
is manufacturing a sleep apnea device needs to register each
individual facility, even though they are a branch location of a
conglomerate.
Industry Assistance CDRH Resources
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CDRH Learn [New]
• Modules include various premarket and post-market information
• Available 24/7
• Certificate generated per topic upon passing post-tests
• Suggest Future topics
• http://www.fda.gov/cdrh/cdrhlearn/
Device Advice
• Self-service website
• Searchable by topic
• http://www.fda.gov/cdrh/devadvice/
Division of Small Manufacturers, International, and Consumer Assistance (DSMICA)
• Technical Assistance for the Medical Device Industry
• 800-638-2041 or 240-276-3150
• DSMICA@cdrh.fda.gov
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Industry Assistance CDRH Learn
What is CDRH Learn?
• New Online Training tool
• Multi-Media Presentation
• Available 24/7
• Certificate generated per topic upon passing post-tests
• Suggest Future topics
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Examples of Modules
• Overview of Regulatory Requirements: Medical Devices
• Quality System Regulation 21 CFR 820 Basic Introduction
• Registration & Listing (under development)
http://www.fda.gov/cdrh/cdrhlearn/
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Key FDA Contacts
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Greg Holt,
FDA Field Officer in Alaska
Business: (907) 271-1246
E-mail: greg.holt@fda.hhs.gov
Ernest Smith FDA
Business: (240) 276-0115 ext 5
E-mail: ernest.smith@fda.hhs.gov
Centers for Devices and Radiological Health, Consumer Safety Officer
Industry Resources
Contact NADL
800/950-1150
www.nadl.org
www.fda.gov/cdrh